The taste, color and texture of pharmaceutical dosage forms are important factors in patient compliance with dosing regimens. Since pharmaceutically active ingredients often have unpleasant tastes or textures for example, a wealth of taste masking and texture masking technology has developed in the art. However, such technology is typically applied during manufacturing of dosage forms, and therefore not subject to a high degree of consumer customization. Unfortunately, different patients often prefer different product attributes, tire of certain product attributes. Pediatric patients can be especially finicky about taste and texture, making administration of medicine to them particularly difficult.
Pharmacists sometimes custom flavor dosage forms for patients. However, the current practice suffers from several limitations. First, not all flavoring agents are physically and/or chemically compatible with all of the excipients typically employed in liquid dosage forms, such as suspension vehicles. Accordingly, it is often necessary to test the compatibility and stability of known flavoring agents with the liquid dosage forms with which they are intended for combination. Second, the addition of commercially available flavor systems to a pre-flavored liquid product can result in flavor incompatibilities. Certain flavors can overwhelm others, or certain “off-notes” of one flavor can increase in the presence of another flavor. Third, the flavoring agents used by pharmacists are typically highly concentrated compositions that require professional training to use. They are unsuitable for use by a consumer.
A method for preparing a flavored liquid medicament, particularly a pediatric preparation, is disclosed in U.S. Pat. No. 6,428,808 B1. The method comprises addition of a flavoring vehicle to an unflavored liquid medicament that has an unacceptable taste.
Applicants have now discovered that pharmaceutical dosage forms may be customized directly by the consumer by providing customization agents that are physically and chemically compatible with the dosage forms, i.e., ready to use. These customization agents, specifically flavoring agents, sweetening agents, or texturizing agents, are suitable for combination with the dosage form just prior to administration. Flavoring agents in particular are advantageously compatible for adding to dosage forms already containing a first flavor, so that the dosage form is initially provided to the consumer with at least some flavor, which may be subsequently customized as desired prior to administration.